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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, straight
510(k) Number K112137
Device Name COMFORTGLIDE INTERMITENT CATHETER
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Applicant Contact STACCI CRONK
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.5130
Classification Product Code
EZD  
Date Received07/26/2011
Decision Date 08/26/2011
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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